Subject: RE: Microwave Thermotherapy for Benign Prostatic Hyperplasia
Date: Wed, 27 Dec 2006 16:01:25 -0500
In October 2000, the FDA issued a Public Health Notification alerting clinicians to the possibility of serious, unanticipated adverse events associated with microwave thermotherapy for treatment of BPH ( http://www.fda.gov/cdrh/safety/bph.html ). One of the recommendations to minimize the risk of injury to the patient was that the treating physician remain in the room with the patient throughout the procedure, carefully monitoring the positions of the urethral and rectal probes.
This recommendation was based on the then current labeling for the devices and remains unchanged today.
Laura Alonge
Issues Management Staff
240-276-3355
